Lotrimin ® Antifungal

Lotrimin ® Antifungal

Drug Labeling and Warnings

Drug Details

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LOTRIMIN ANTIFUNGAL- miconazole nitrate aerosol, powder 
Bayer Healthcare LLC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Lotrimin ®

Antifungal

Drug Facts

Active ingredient

Miconazole nitrate 2%

Purpose

Antifungal

Uses

  • proven clinically effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis)
  • for effective relief of itching, cracking, burning, scaling and discomfort

Warnings

For external use only

Flammable: Do not use while smoking or near heat or flame

When using this product

  • avoid contact with the eyes
  • use only as directed. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal
  • contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F.

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks (for athlete's foot and ringworm) or 2 weeks (for jock itch)

Do not use on children under 2 years of age except under the advice and supervision of a doctor.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • wash affected area and dry thoroughly
  • shake can well and spray a thin layer over affected area twice daily (morning and night)
  • supervise children in the use of this product
  • for athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily
  • for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
  • if condition persists longer, ask a doctor
  • this product is not effective on the scalp or nails
  • in case of clogging, clean nozzle with a pin

Other information

store between 20° to 25°C (68° to 77°F)

Inactive ingredients

isobutane, SD alcohol 40-B (8% v/v), stearalkonium hectorite, talc

Questions?

1-866-360-3266

Distribution

Distributed by: Bayer HealthCare LLC, Whippany NJ

PRINCIPAL DISPLAY PANEL - 133 g Can Label

Powder Spray

goes on dry

NDC: 11523-0544-2

LOTRIMIN® AF

ANTIFUNGAL

miconazole nitrate

Clinically Proven To Cure

Most Athlete's Foot

  • Relieves Itching,

    Burning, Cracking

    & Scaling

NET WT 133g (4.6 OZ)

Label

LOTRIMIN  ANTIFUNGAL
miconazole nitrate aerosol, powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 11523-0544
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ISOBUTANE (UNII: BXR49TP611)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
Colorwhite (White to off-white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 11523-0544-2133 g in 1 CAN; Type 0: Not a Combination Product09/01/1993
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C09/01/1993
Labeler - Bayer Healthcare LLC. (112117283)

Revised: 8/2017
 
Bayer Healthcare LLC.


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